MODULE FOR ASSESSING AND STRENGTHENING THE QUALITY

HIV STRATEGIC INFORMATION FOR IMPACT

SEPTEMBER 2020

MODULE FOR ASSESSING AND STRENGTHENING THE QUALITY OF VIRAL LOAD TESTING DATA WITHIN HIV PROGRAMMES AND PATIENT MONITORING SYSTEMSWEB ANNEX D: DETAILED CLINICAL FACILITY VIRAL LOAD ASSESSMENT TOOL

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Web Annex D: Detailed clinical facility viral load assessment tool 1

Objectives

Part 1: Facility profile and scorecard• To gather situational analysis information regarding

the facility’s readiness to provide routine viral load (VL) monitoring for people receiving antiretroviral therapy (ART)

• To assess clinical systems in place for implementing routine VL testing and interpretation

• To serve as a scorecard for monitoring and documenting improvements

Part 2: Scoring and summary To provide a standardized measurement to document baseline situation and clinical facility improvements.

Note: for the purposes of this VL data quality (DQ) assessment module, questions focusing on data quality, flow, tools and reporting are highlighted. The greyed-out sections focus on service delivery and quality but are still important to include. It is intended that countries select and use the questions that are appropriate for their context and monitoring needs to enable joint assessment of service delivery and data quality.

Part 3: Data quality assurance Routine checks to assess the completeness and consistency of reporting of VL data and data elements across different sources.

Part 4: Debrief To discuss findings and recommendations with key stakeholders.

• Debrief scorecard findings with facility in-charge, ART clinicians, laboratory manager, quality officer and/other staff

• Discuss any corrective actions and/or recommendations with facility in-charge, ART clinicians, laboratory manager, quality officer and/or staff

ScoringFor each element, assess level of completion by identifying objective evidence.

Check:

• Yes = complete and fully implemented = 1 point

• Partial = evidence of some elements in place = 0.5 point

• No = no evidence = 0 point

• Enter N/A in comment section if the element is not applicable to the situation and exclude from scoring

• Sections 2 and 3 contain questions that require observation of materials for score = yes; these questions are indicated by the icon .

• Tally the total points for each section and transcribe to the table in Part 2: Scoring and summary

Instructions for assessors• Familiarize yourself with the scorecard

• Explain the objectives of the scorecard to facility in-charge, ART clinicians, laboratory manager or officer, monitoring and evaluation officer or data clerk or designee before completing the scorecard

• Request the availability of registers, tools and patient records (when applicable) at the beginning to make the review more efficient (see the last page with the table of requested documents)

– National guidelines – ART register – VL requisition form – Standard operating procedures and job aids for VL

ordering, sample collection, documenting and recording results, returning results, patient management and filling out monitoring and evaluation tools

– VL sample collection log – Specimen transport log – Patient and community education materials related to VL – Enhanced adherence counselling tools – High VL register – 5 adults, 3 children and 2 pregnant or breastfeeding

women

• Administer sections 1 and 2 to the ART clinician (facility in-charge may provide input)

• Administer section 3 to the monitoring and evaluation officer or data clerk (may need input from ART clinician)

• Administer sections 4, 5 and 6 (when applicable) to the laboratory manager or officer

• Complete the scorecard by going through all the sections

WEB ANNEX D DETAILED CLINICAL FACILITY VIRAL LOAD ASSESSMENT TOOL

Web Annex D: Detailed clinical facility viral load assessment tool2

PART 1 BASIC SITE AND ASSESSMENT INFORMATION AND FACILITY CHARACTERISTICS

PLEASE PROVIDE RELEVANT INFORMATION IN THE SUMMARY TABLE BELOW

Date of assessment (DD/MM/YYYY): First assessment? Yes No

Start time: End time:If no:

Date last assessed (DD/MM/YYYY):Facility Name:

Facility code:

Facility level (circle one):

Regional, provincial, zonal

Referral centre, centre of excellence

District

Health centre

Dispensary

Health post

Other (please specify to reflect the country context):

Region, province, zone: Affiliation (circle one):

Government

Private

Faith-based organization

Nongovernmental organization

Other:

Assessor name number1: Assessor name number2:

1.0 FACILITY CHARACTERISTICS

Administer sections 1 and 2 to the ART clinician (the facility in-charge may provide input).

Response

When did VL testing begin at this facility? (MM/YYYY)

How many patients are currently receiving ART?

How many patients are receiving second-line ART?

Number Service outlets Comments

Total number of expert clients

Provide any additional comments on challenges that you have with relation to human resources available for HIV treatment and HIV-related testing (such as VL) in the comments


2.0 SERVICE DELIVERY AND VIRAL LOAD MONITORING TOOLS AND REPORTING QUESTIONS Points

Type of testing, tools, documentation and staff responsibilities

Section Yes Partial No Comments Score/total (excluding N/A)

2.1

Is your facility requesting/ordering VL testing?

Targeted (tick partial and enter to whom in comments)

Routine (score yes, if all populations; score partial for only specific subpopulations)

2.2 Are VL testing algorithm job aids posted for the following populations?

2.2.1 Adults?

2.2.2 Adolescents (10–19 years)?

2.2.3 Children (0–9 years)?

2.2.4 Pregnant or breastfeeding women?

2.3 Are there clinic staff tasked with the following activities?

2.3.1 A focal person identified at the ART clinic who is responsible for VL-related activities?

2.3.2 Completion of the VL requisition form?

2.3.3 VL sample collection?

2.3.4 Packaging and referral?

2.3.5 Documents the receipt of VL test results from the lab (clarify whether processing lab versus on-site mini-lab?)? (Note: mini-lab refers to a location staffed by a lab technician or technologist with capacity for sample centrifugation and where other diagnostics are performed such as Gram stain, AFB smear, urinalysis, etc.)2.3.6 Reviews VL test results and separates VL <1000 versus ≥1000 copies/mL?

2.3.7 Documents VL test results in the patient record?

2.3.8 Follows up on VL test results that have not been received from the lab (pending, rejected or outstanding results)?2.3.9 Communicates VL test results to patients and arranges next appointment? 2.3.10 Is there a position or job description for the VL focal person outlining roles and responsibilities?

Pre-test


2.4 Is the paper VL sample requisition form well-stocked (>3 months)?

2.5Are standard operating procedures developed for requesting VL tests and collecting VL samples that include the following?

2.5.1 Filling out the VL sample requisition form?

2.5.2 Collecting VL samples?

2.6Is there a facility-level VL literacy education programme for patients?

2.7Do you have patient education materials on VL literacy?

2.8Is there a community education programme on VL literacy (presentations to promote community awareness)?

For each of the sections listed below, please check yes, partial or no, where applicable. Indicate “yes” only when all elements are satisfactorily present. Provide comments for each “partial” or “no” response. State N/A in the comments section if not applicable. Some questions require observation of materials for score = “yes” and are indicated by the icon .


Post-test


2.9

Are VL results sent from the VL testing lab to your facility electronically (the lab sends results via email to the facility, the clinic can access results or the lab information system or the results are directly entered into electronic patient record)?

2.10Once the VL test results are received from the central lab or hub, is there a system to review the results in your facility?

2.11When the VL results are reviewed, are they routinely separated into VL ≥1000 versus <1000 copies/mL?

2.12

Are the VL results entered into a VL sample and results tracking log (maintained at the clinic site) with the expected data fields complete (such as result and date of result return to the facility)? Describe the process (who, when, where?) in the comments

Process Enter N/A if no separate VL sample and results tracking log kept in the facility

2.13Is there a process to ensure that patients receive their results?

Describe the process of placing VL results in patient files (who, when, where, hard copy and/or electronic?)

2.14 Are standard operating procedures developed for recording VL test results upon return to sites in the following?

2.14.1 Patient chart

2.14.2 High VL register

2.15

Are patients receiving their results in a specified time period?

If yes, score based on average period of time:

within 1 month (score= yes)

1–3 months (score= partial)

>3 months (score= no)

Describe the process of follow-up with the lab if the results are not returned to facility after the expected turnaround time:

If the average turnaround time is highly variable, note in the comments column and score as N/A

2.16Is there a standard operating procedure for managing patients with suppressed VL (<1000 copies/mL)?

2.17

Is there a standard operating procedure for managing patients with non-suppressed VL (≥1000 copies/mL) AND does it include specific actions for the various subpopulations (such as pregnant or breastfeeding women or people living with HIV with advanced disease)?

2.18Are there tools to track patients with VL ≥1000 copies/mL?

2.19Is there a process for enhanced adherence counselling for patients with VL ≥1000 copies/mL?


Enhanced adherence counselling


2.20 Are there job aids for use during enhanced adherence counselling for patients with VL ≥1000 copies/mL specific to the following populations?

2.20.1 Adults?

2.20.2 Adolescents (10–19 years)?

2.20.3 Children (0–9 years)?

2.20.4 Pregnant or breastfeeding women?

2.21Is there a process in place for patients who do not return for enhanced adherence counselling sessions?

Managing non-suppressed VL and regimen failure


2.22Is there a system for expert consultation to manage patients on first-line regimens with non-suppressed VL (≥1000 copies/mL; potential first-line regimen failure)?How many enhanced adherence counselling sessions are held between VL tests? When is the next VL test preformed after the first indicating non suppression (≥1000 copies/mL)

2.23Is there a standardized process for switching ART regimens for patients for whom a first-line regimen is failing?

2.24

2.24.1 Is there an onsite multidisciplinary team or committee on site that reviews patients who have VL non-suppression and regimen failure for ART regimen switches?

Only applicable if switch decisions are recommended to be taken by multidisciplinary team or committee. If not, mark as N/A

2.24.2 Does the multidisciplinary team or committee meet at least monthly?2.24.3 Is there a mechanism for onsite same-day decision making for ART switch in specific populations (such as pregnant or breastfeeding women)?2.24.4 Are multidisciplinary team actions from the previous meeting documented?

2.25 Are second-line ART regimens available at this site for the following populations?

2.25.1 Adults?

2.25.2 Children?

2.26Is there a standardized process for switching ART regimens for whom a second-line regimen is failing?

2.27

Is third-line ART available

Is there a standardized process for switching ART regimens for patients for whom a third-line regimen is failing?

Describe the process for switching to a third-line regimen


HIV care and treatment practices


2.28

2.28.1 Are differentiated service delivery models implemented in this facility distinguishing stable versus unstable patients using VL criteria? Please indicate in the comments the differentiated service delivery model used by the facility: monthly, 3-month or 6-month drug dispensing

Describe the differentiated service delivery model: multi-month ARV dispensation

Monthly

3 months

6 months

Other, specify:

Review how many patients with suppressed VL (<1000 copies/mL) were identified as eligible for differentiated service delivery and, of those, how many received differentiated care (select time period from the following: past month or past 3 months.

Number eligible for differentiated service delivery (multi-month ARV drug dispensing):

Number receiving differentiated care (multi -month ARV drug dispensing):

Note the time period:

2.28.2 Is there an standard operating procedure to refer patients with suppressed VL (<1000 copies/mL) to less intense models of care?

2.0 Service delivery, tools and reporting SCOREScore/Total (excluding NA)


3.0 MONITORING AND EVALUATION Points

Administer this section to the monitoring and evaluation officer or data clerk (may need input from an ART clinician).


3.1 Do current patient cards (and/or electronic medical records (EMR) include field(s) to monitor VL test (including test ordered and results)?

If an EMR or laboratory information system is used, please list the name of the system(s):

3.2Do current ART registers include field(s) to capture VL tests and result data (including treatment initiation month, date test was requested and result)?

3.3

Do current reporting tools (paper and/or electronic) from sites include fields to report on key variables, including the number of patients who received a VL test, the number of patients who have suppressed VL and for routine reporting on VL testing and outcomes?

3.4For facilities with EMR or laboratory information management system (LMIS), is there a backlog of data entry?

Explanation for backlog:

How often are data entered into the system:

Daily

Weekly

Monthly

Other

Score 1 point for “no” and 0 for “yes”

3.5 Does the facility keep a paper backup other than patient charts of VL test results?

If yes, is it:

ART register

Laboratory results form

Another tool, please specify:

3.6

Can monitoring and evaluation systems and tools at sites track VL testing outcomes for cohorts of patients (such as VL test results for patients 6 and 12 months after initiating ART)?

3.7Is there a high VL register (or specific register) on site to track patients who have high viral load results (≥1000 copies/mL)?

3.8Is there a plan to train service providers, lab staff, monitoring and evaluation staff and other site staff on the correct completion of monitoring and evaluation tools?

3.9

Check with the data clerk, HMIS officer or service provider whether the facility follows quality control procedures for data entry of VL testing into EMR, laboratory information management system (LIMS) or a paper-based register. Request to see documentation of these procedures.

3.10

Are there regular reviews (monthly, quarterly, etc.) of VL data on site? If yes, score yes and describe in the comments. In addition, are any of these data quality assurance activities implemented remotely or through online platforms? (please indicate in the comments)

3.11

Is there a plan to mentor service providers, lab staff, monitoring and evaluation staff and other site staff on correct completion of monitoring and evaluation tools? Describe in the comments.

3.12 Does the facility have a tool that can be used for conducting internal data quality checks that includes viral load monitoring data?



3.13Are there plans to compare data from the LIMS or laboratory database for the site to data from site-level records, registers, logbooks etc.?

3.14Does the site receive routine reports from the LIMS or laboratory database? If yes, describe what variables are sent and how often.

3.0 Monitoring and evaluation scoreScore/Total (excluding NA)

4.0 LAB-RELATED QUESTIONS Points

Administer this section (where applicable) to the laboratory manager or officer.

Answer the respective questions based on the type of sample collected: for whole blood only collection, complete questions 4.1–4.8 and 4.13–4.36; for dried blood spot (DBS) only collection, complete questions 4.1–4.3 and 4.9–4.36. (Note: if your facility collects both DBS and plasma, proceed with answering all questions 4.1–4.36). If facilities do not have a mini-lab (a mini-lab has a trained technician or technologist), skip questions 4.5–4.8. Some questions require observation of materials for score = “yes” and are indicated by the icon .


4.1 Do you have a phlebotomist?Where is the phlebotomist located?

4.2 Is there an individual who is capable of collecting venous samples for the following populations?

4.2.1 Adults ≥15 years?

Children

4.2.2 <5 years?

4.2.3 5–10 years?

4.2.4 11–15 years?

4.3 Are all the fields of the VL requisition form completed? Note which fields are most often inaccurate or incomplete.

4.4

Does your site have a mini-lab? (has a trained technician or technologist who collects and prepares VL samples or where point-of-care testing is performed) If no, skip questions 4.5–4.8.

4.5 Do you have a working centrifuge to separate plasma?

4.6 Were you trained to centrifuge blood tubes?

4.7 Do you have a working refrigerator and/or freezer?

4.8Can you store samples at the recommended temperature for whole blood and plasma before transport to the laboratory for VL testing?

Is the temperature of the refrigerator and/or freezer monitored daily?

4.9 Is there an individual capable of preparing the following VL sample types at this site?

4.9.1 DBS from venous blood?

4.9.2 DBS from finger prick or heel prick?


DBS preparation and packaging (complete this section only if the facility prepares DBS; if not, then proceed to 4.13)

Note where the DBS are being prepared


4.10 Is it the same location as whole blood collection?

4.11Is the same person who collected the whole blood preparing the DBS?

4.12

4.12.1 Do you use powder-free gloves to collect DBS?

4.12.2 Do you prepare and pack DBS samples?

4.12.3 Do you collect at least three full blood spots per DBS card?4.12.4 Do you dry DBS samples at least 4 hours before packaging?4.12.5 Do you separate the DBS cards with glassine paper if you package multiple cards?

4.12.6 Do you seal the dried DBS cards in ziplock bags?

4.12.7 Do you include at least one desiccant packet per card in your packaging?4.12.8 Do you include a humidity indicator card in your DBS package?

Specimen transport


4.13

4.13.1 Is there a specimen transport log?

4.13.2 Is the specimen transport log reviewed for adherence to transport and time conditions?4.13.3 Does your specimen transport system support cold chain? (relevant for sites that collect and transport blood or plasma samples only; skip if site is using DBS only)

Do you use coolers and ice packs?

4.13.4 Is the specimen transport temperature monitored? (relevant for sites that collect and transport blood or plasma samples only; skip if site is using DBS only)

Do you use a temperature logger?

4.14Which days are the samples supposed to be picked up from the facility?

Mon Tue Wed Thur Fri

How often?

Daily

Weekly

Monthly

Other

4.15Was the last batch of samples picked up on the designated day(s)?

4.16Is the VL dispatch form correctly filled with patient names, unique ART number, age, gender, sample type, name of dispatcher, date of sample dispatch and VL focal person’s name and phone number? If no to any, specify.

4.17

Is the VL dispatch form reviewed with a response for rejection (Y/N), indicating the name of the recipient and the date the samples are received? If no to any, specify.


Specimen quality


4.18 Do you track the monthly specimen rejection rate?

4.19 Can you show the monthly rejection rate for each of the past 3 months? Score = yes if rate is shown for each of the 3 months, score = partial if rate is shown for 1–2 months.

Note rejection rates for any or all months

4.20Was the sample rejection rate less than 3% in the past 3 months? (for example, 1 of 30)? (Score = no if >3%; score = yes if <3%)

4.21Is there a system for reviewing non-returned VL results in the sample daily log?

Is it done routinely? (such as each Friday?)

4.22

4.22.1 Is there a feedback system at your facility for rejected or inadequate samples?4.22.2 Who receives rejected sample notifications (telephone call or hard copy) and makes notifications in the VL sample daily log?

4.23Do you routinely receive rejected/inadequate sample communications (such as call or hard copy) from the central testing laboratory?

Consumables and reagents


4.24Has there been a stock-out of VL sample collection consumables in the past 3 months?

4.25

4.25.1 Is there an inventory system in place for all VL sample collection consumables?4.25.2 Are all VL sample collection consumables stored according to the manufacturer’s recommendations?

4.25.3 Are all VL sample collection consumables used or discarded within their expiration date?

4.26 Are there adequate storage facilities for reagents?

Laboratory safety


4.27

4.27.1 Does your site have procedures for handling and disposing of biohazardous material?

4.27.2 Do you have blood spill kits?

4.27.3 Are there standard operating procedures to manage blood spills?

4.27.4 Have you had spill kit stock-outs in the past year?

4.27.5 Is there documentation that the laboratory personnel have been trained on handling biohazardous material, workplace safety and spill management? (if no lab personnel, score N/A)

4.27.6 Are gloves always available?

4.27.7 Are other biohazard materials available (such as biohazard bags and sharp containers)?


Logbooks, standard operating procedures and job aids


4.28

4.28.1 Is there a site-level sample daily log sheet or logbook that enables documentation of each VL test ordered and sent to the lab?4.28.2 Does the daily log indicate which VL specimens come from a pregnant or breastfeeding woman, PLHIV with advanced disease or other priority populations ?4.28.3 Do you currently give priority to processing samples that come from pregnant or breastfeeding women?4.28.4 Is there a standard operating procedure to give priority to processing samples that come from pregnant and breastfeeding women?

4.29 Is there a standard operating procedure for filling out the sample daily log sheet or logbook?

4.30 Is the sample transmitter form, sample delivery checklist or chain of custody form filled out to indicate the number of VL tests ordered?

4.31 Is there a standard operating procedure for filling out the sample transmitter form, sample delivery checklist or chain of custody form?

4.32 Is there a standard operating procedure for rejected sample notification?

4.33Is there a job aid for spotting DBS cards?

4.344.34.1 Is there a standard operating procedure for DBS preparation?4.34.2 Is there a standard operating procedure for phlebotomy if performed instead of or in addition to DBS?

4.35

4.35.1 Are there job aids for VL specimen storage for all types of samples collected (such as plasma and DBS)?4.35.2 Are there job aids for VL specimen packaging and transport?

4.35.3 Are there job aids for VL specimen rejection?

4.36Are national forms well stocked (>3 months) for the following?

4.36.1 Sample daily log or logbook?

4.36.2 Sample transmitter form or sample delivery checklist?

4.36.3 Specimen transport log?

4.0 Lab scoreScore/Total (excluding NA)


5.0 FACILITIES WITH VL POINT-OF-CARE TESTING (SKIP THIS SECTION IF VL POINT-OF-CARE TESTING IS NOT AVAILABLE) Points


5.1

5.1.1 Is your facility and/ or mini-lab enrolled in an external quality assurance programme?5.1.2 Identify the VL point-of-care platform and average number of tests run per week

5.2

5.2.1 Did this facility pass the previous external quality assurance send out?5.2.2 If your laboratory did not pass the previous external quality assurance send out, was corrective action taken? (skip if N/A or passed external quality assurance send out)

5.3Are point-of-care VL reagents stored according to the manufacturer’s recommendations?

5.4Is there an effective point-of-care VL equipment maintenance contract in place?

5.5 Was there equipment failure in the past 6 months?

5.6Was the time it took for the point-of-care device to be repaired greater than 1 month?

5.7

5.6.1 Have either the lab technicians or nurses been trained to perform VL point-of-care testing?

Circle point-of-care testers: lab technician(s) or nurse(s)

5.6.2 Have all individuals who perform VL testing passed initial competencies? (note: if N/A, leave score blank)5.6.3 Have all trained technicians or nurses who perform VL testing passed competencies? In the last year? (Note: if N/A, leave score blank)

5.8Is there annual refresher training with records of such training?

5.0 VL point-of-care testing scoreScore/Total (excluding NA)


SectionPoints given

Total possible points (excludes N/A responses)

% score

Level Assessor’s comments

2.0 Service delivery and VL monitoring tools and reporting

3.0 Monitoring and evaluation

4.0 Lab related

5.0 VL point-of-care testing

Overall readiness score

Levels % score Description of results

Level 0 Less than 40% Needs improvement in all areas and immediate remediation

Level 1 40–59% Needs improvement in specific areas

Level 2 60–79% Moderate readiness

Level 3 80–89% Approaching readiness

Level 4 90% or higher Meets readiness criteria

PART 2 SCORING CRITERIA

Facility name Assessment date (DD/MM/YYY)

Each element marked will be assigned a point value:

• Items marked “yes” receive 1 point each.

• Items marked “partial” receive 0.5 points each.

• Items marked “no” receive 0 points each.

The total points scored for each section should be tallied and recorded at the end of the section.

The overall total points obtained by each facility assessed will be weighted to correspond to a specific performance level.

Total points given: Overall % Level


PART 3 DATA QUALITY CHECKS (COMPLETENESS CHECKS AND CROSS-VALIDATION ACTIVITIES)Use the table below to assess the completeness of VL monitoring tools and reporting and cross-validate data elements in lab requisition forms across data sources

Indicator or monitoring area

Source(s) Methods Response Comments

1. Eligible patients have VL testing and results documented in patient file (completeness check 1)

ART register and patient files

From today’s date: month/year For example, Jan 2020

Go back 6–8 months: month/year For example, Jun-Apr 2019

Check the ART register for patients who initiated 6–8 months ago. Make note of the approximate number of patients

For example, n = 100

Select every nth file to give you a total of 10% of the above number of patients (do not include patients who are lost to follow-up)

Make note of the ART numbers and give to the data clerk to pull the required number of patient files

For example, every 20th file out of 100: 5 files selected

Check the files to see how many had a VL result documented

Do not include in the count if the VL test was ordered but there is no result

For example, 2

Numerator: number of ART files with a documented VL result

Denominator: total number of files reviewed

For example, 2/5=40% Numerator/denominator (%):

Cross-validation of patient files versus EMR or VL testing database

Facility VL sample and results tracking log, patient file and VL testing lab database (VL sample management system)

Randomly select and review 10% of patient files with VL results documented within the past month. Check the onsite VL testing lab database to verify whether the result in the patient file matches the most recent VL result in the electronic medical record (EMR) or VL testing lab database

Tick yes if the VL result in the patient file matches the most recent result in the VL testing database, EMR or LMIS

Yes No

Total yes XX

Total no XX

% of sampled patient files with discordant VL results in paper patient files versus VL database:

N/A (if the data from testing lab are not accessible)

Facility VL sample and results tracking log, patient file, site EMR or electronic patient database

Randomly select and review 10% of the patient files with VL results documented within the past month. Check the onsite EMR or electronic patient database to verify that the result in the patient file matches the most recent VL result in the EMR

Tick yes if the VL result in the patient filed matches the most recent result in the EMR

Yes No

Total yes XX

Total no XX

% of sampled patient files with discordant VL results in paper patient files versus EMR:

N/A (if data from the EMR or electronic patient database are not accessible)


Indicator or monitoring area

Source(s) Methods Response Comments

2. VL requisition form completion cross-validation with patient files

VL requisition form

Make note of the ART number for every nth VL requisition form from the past month to give you a total of 10% of files with VL results documented in the past 1 month. Then give the ART numbers to the data clerk to pull the patient files

N/A (if VL requisition forms are not accessible)

VL requisition form

Are the fields listed below in the VL requisition form filled accurately and completely compared with the data in the patient file? Tally the responses for each patient file. Mark “yes” if the field is both accurate and complete. If no/missing or incorrect, make a note in the comments

Yes (tally for each VL form)

No (tally for each VL form)

Total “yes”

Total “no”

% of discordance (total “no”/number of files reviewed) times 100

Requesting health facility name

For example, IIII

For example, II

4 2

Unique ART number

Date of birth or age

Gender

Sample type

Current ART regimen

Pregnancy and breastfeeding status

Indication for VL testing

Requesting clinician

Phone number

VL request date

Review the first 5 entries from the prior month. Are the dates of sample collection and results received complete?

Yes

No

3. Clinic VL results receipt and completeness check

VL sample and results tracking log and patient file

Review random entries from the VL sample and results tracking log that were returned to the facility about 1–2 months ago for 10% of patient files with VL results documented in the past 1 month. Make note of the ART numbers and ask the data clerk to pull the corresponding patient files.

How many patient files have VL results documented? (numerator: number files with VL result documented; denominator: number files reviewed). Check both electronic and paper patient files.

Results documented (For example, 2/3, 67%)

Numerator/denominator (%):

___/____ ( %)

N/A (if no results have been returned within the past 2 months)

Patient file How many have the date of sample collection correctly documented with the VL result in the patient file or ART card?

(numerator: number with the date of sample collection correctly documented with VL result; denominator: number of files reviewed)

Date of sample collection with VL result (For example, 1/3, 33%)

Numerator/denominator (%):

___/____ ( %)


RECORDING SHEET FOR PATIENT ART NUMBERS FOR DATA CHECKS IN THE CLINICAL FACILITY VIRAL LOAD SERVICE QUALITY TOOLData sources for review and selection of ART numbers for patient file reviews

Instructions: Request to see each of the data sources listed below. Select the ART numbers from each data source according to the selection criteria and document the ART numbers in the far-right column. Ask the data clerk to pull the patients files for each ART number on the list. Ensure that you receive this list back, along with the pulled patient files, and refer to the list to review the appropriate files for each section of the tool.

Data Source Section Selection criteria for patient files Patient ART number

ART register 2 Among patients who initiated ART 6–8 months ago, document ART numbers for every nth patient to get a total of 10% of these patient files

1.

2.

3.

4.

5.

n. etc.

VL sample and results tracking log

2 ART Number of of10% of random patients whose VL results have been returned within the past one month

1.

2.

3.

n. etc.

6 ART numbers of 10% random patients whose VL results have been returned 1–2 months ago

1.

2.

3.

n. etc.

VL requisition forms 3 ART numbers of random selection of 10% patient files with VL results in the past month

1.

2.

3.

4.

5.

n. etc.

High VL register 7 ART numbers of 5 random patients from high VL register

1.

2.

3.

4.

5.

n. etc.


PART 4 ASSESSOR’S SUMMATION REPORT FOR VL SCALE-UP FACILITY READINESS

Facility name

Person in-charge name

Signature

Total points scored (exclude N/A) = a Total possible points = b % score = (a/b) times 100

Site type

Assessor name(s)

Signature Date

Duration of assessment

Section number

Deficiency or issue observed Corrective actions Assessor’scomments

Recommendations

Immediate Follow-up Actions Timeline and person responsible

REQUESTED DOCUMENTS (TOOLS, REGISTERS, STANDARD OPERATING PROCEDURES)

Document Found (check if yes)

National guidelines

ART register

VL requisition form

Standard operating procedures and job aids for documenting and recording results

Standard operating procedures and job aids for returning results

Standard operating procedures and job aids for filling out monitoring and evaluation tools

VL sample collection log

Specimen transport log

For more information, contact:

World Health Organization Department of HIV/AIDS 20, avenue Appia 1211 Geneva 27 Switzerland

E-mail: [email protected]

www.who.int/hiv

ISBN 978-92-4-001042-0 (electronic version)

© World Health Organization 2020. Some rights reserved. This work is available under the CC BY-NC-SA 3.0 IGO licence.